E6-16329. Privacy Act of 1974; Report of a New System of Records

AGENCY:

Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS).

ACTION:

Notice of a New System of Records (SOR).

SUMMARY:

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR titled “Low Vision Rehabilitation Demonstration (LVRD),” System No. 09-70-0582. The program is mandated by Section 641 of the Medicare Prescription Drug Improvement and Modernization Act of 2003 (MMA) (Public Law (Pub. L.) 108-173), enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The LVRD program seeks to establish a new demonstration project to examine Medicare beneficiaries who are diagnosed with moderate to severe visual impairment and who may be eligible to receive covered vision rehabilitating services. Rehabilitation may be conducted under general supervision of a qualified physician in an appropriate setting including in the home of the beneficiary receiving the services. Improvements in these areas are expected to generate savings to the Medicare program to offset the costs of the performance payments.

The primary purpose of the system is to collect and maintain identifiable information on Medicare beneficiaries who participate in Medicare Part B fee-for-service coverage, qualified physicians, such as ophthalmologists or optometrists, qualified occupational therapists, and vision rehabilitation therapists who are certified by the Academy for Certification of Vision Rehabilitation Professionals. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or grantee; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain health benefits programs. We have provided background information about the new system in the Supplementary Information section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See Effective Dates section for comment period.

Effective Dates:

CMS filed a new system report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security and Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB) on 09/27/2006. In any event, we will not disclose any information under a routine use until 30 days after publication in the Federal Register or 40 days after mailings to Congress, whichever is later. We may defer implementation of this system or on one or more of the routine uses listed below if we receive comments that persuade us to defer implementation.

ADDRESSES:

The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, Office of Information Services, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location by appointment during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern time.

FOR FURTHER INFORMATION CONTACT:

Joel Greer, Social Science Research Analyst, Division of Beneficiary Research, Research & Evaluation Group, Office of Research Development and Information, CMS, Mail Stop C3-18-07, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. The telephone number is [phone] or e-mail [e-mail].

SUPPLEMENTARY INFORMATION:

Section 641 of MMA requires the Secretary of Health and Human Services to carry out a nationwide outpatient vision rehabilitation services demonstration project. Under this LVRD, Medicare will cover vision rehabilitation services for people with a diagnosis of moderate or severe vision impairment including blindness that is not correctable by conventional methods, such as glasses or surgery. Demonstration covered services will only be available to Medicare beneficiaries who live in one of the specified demonstration locales and must be prescribed by a qualified physician, such as an ophthalmologist or an optometrist who also practice in one of the specified demonstration locales.

LVRD locales will include New Hampshire, New York City (all 5 boroughs), Atlanta, GA., North Carolina, Kansas, and Washington State. Eligible beneficiaries who live in these areas and receive their medical eye care from an ophthalmologist or an optometrist who practice in these areas could be covered for up to 9 hours of rehabilitation services provided in an appropriate setting, including in the home. For many with visual impairments, rehabilitation training can help them maintain their independence and quality of life. Rehabilitation can help prevent accidents, like falls and burns that often occur when someone cannot navigate well due to vision loss.

Under LVRD, Medicare will cover vision rehabilitation services for people with a diagnosis of moderate or severe vision impairment including blindness that is not correctable by conventional methods, such as glasses or surgery. Rehabilitation may be conducted under general supervision of a qualified physician in appropriate settings including in the home of the beneficiary receiving the services. Rehabilitation must be prescribed by a qualified physician and administered under an individualized, written plan or care developed by a qualified physician or qualified occupational therapist in private practice (OTPP). The plan of care must contain a specific diagnosis of visual impairment and must assure that vision rehabilitation services are medically necessary and the beneficiary receiving vision rehabilitation is capable of deriving benefit from the rehabilitation. Under the demonstration, services will be covered when provided by a qualified occupational therapist, or by a low vision therapist, orientation and mobility specialist, or vision rehabilitation therapists (aka rehabilitation teachers) who are certified by the Academy for Certification of Vision Rehabilitation Professionals (ACVREP).

Rehabilitation will be judged completed when the treatment goals have been attained and any subsequent services would be for maintenance of a level of functional ability or when the patient has demonstrated no progress on two consecutive visits. All services covered under this demonstration are one-on-one, face to face services. Group services will not be covered.

Some areas of the country provide Medicare coverage for vision rehabilitation services under local coverage decisions (LCDs). LCDs allow Medicare to pay for vision rehabilitation when provided by qualified personnel, such as occupational therapists. LCDs may also allow coverage for vision rehabilitation when provided in the home by a qualified OTPP under general supervision. The LVRD does not supersede LCDs whether services are provided in a demonstration locale, or not. Physicians and other providers who are not practicing in a designated demonstration locale may submit claims for vision rehabilitation as LCD covered therapy services, as before. Physicians and providers who are practicing designated demonstration locale may submit claims as either demonstration-related services or LCD covered therapy services, or both. However, in non-demonstration related services, LCD will not cover services provided by orientation and mobility specialists, low vision therapists, or vision rehabilitation therapists and only OTPP can provide rehabilitation services in the home.

I. Description of the New System of Records

A. Statutory and Regulatory Basis for System

The authority for maintenance of this system is given under the provisions of Section 641 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Public Law 108-173), enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act.

B. Collection and Maintenance of Data in the System

The data will be collected and maintained on individual beneficiaries receiving the services and who participate in Medicare Part B fee-for-service coverage, qualified physicians, such as ophthalmologists or optometrists, qualified occupational therapists, and certified low vision therapists, orientation and mobility specialists, and vision rehabilitation therapists (aka rehabilitation teachers) who are certified by the Academy for Certification of Vision Rehabilitation Professionals.

The data collected will consist of, but not limited to, clinical quality measures collected from physicians participating in the demonstration. The collected information will contain provider name, unique provider identification number, unique demonstration practice identification number, beneficiary health insurance claim number (HICN), beneficiary demographic and diagnostic information relevant to the project.

II. Agency Policies, Procedures, and Restrictions on the Routine Use

A. The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release LVRD information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” Both identifiable and non-identifiable data may be disclosed under a routine use.

We will only collect the minimum personal data necessary to achieve the purpose of LVRD. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS:

1. Determines that the use or disclosure is consistent with the reason that the data is being collected, e.g., to collect and maintain identifiable information on Medicare beneficiaries who participate in Medicare Part B fee-for-service coverage.

2. Determines that:

a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form;

b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and

c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s).

3. Requires the information recipient to:

a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record;

b. Remove or destroy at the earliest time all individually identifiable information; and

c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed.

4. Determines that the data are valid and reliable.

III. Proposed Routine Use Disclosures of Data in the System

A. Entities Who May Receive Disclosures Under Routine Use

The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system:

1. To support agency contractors, consultants, or grantees who have been contracted by the agency to assist in the performance of a service related to this system and who need to have access to the records in order to perform the activity.

We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing agency business functions relating to purposes for this system.

CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give contractors, consultants, or grantees whatever information is necessary for the contractor to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractors, consultants, or grantees from using or disclosing the information for any purpose other than that described in the contract and requires the contractors, consultants, or grantees to return or destroy all information at the completion of the contract.

2. To assist another Federal or state agency to:

a. Contribute to the accuracy of CMS's proper payment of Medicare benefits,

b. Enable such agency to administer a Federal health benefits program, or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds, and/or

Other Federal or state agencies in their administration of a Federal health program may require LVRD information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided.

3. To assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects.

The LVRD data will provide for research or in support of evaluation projects, a broader, longitudinal, national perspective of the status of Medicare beneficiaries. CMS anticipates that many researchers will have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare beneficiaries and the policy that governs the care.

4. To support the Department of Justice (DOJ), court or adjudicatory body when:

a. The agency or any component thereof, or

b. Any employee of the agency in his or her official capacity, or

c. Any employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or

d. The United States Government is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records.

Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS' policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved.

5. To assist a CMS contractor (including, but not necessarily limited to fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such program.

We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual relationship or grant with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste, and abuse.

CMS occasionally contracts out certain of its functions and makes grants when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor or grantee whatever information is necessary for the contractor or grantee to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor or grantee from using or disclosing the information for any purpose other than that described in the contract and requiring the contractor or grantee to return or destroy all information.

6. To assist another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any state or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs.

Other agencies may require LVRD information for the purpose of combating fraud, waste, and abuse in such Federally-funded programs.

B. Additional Provisions Affecting Routine Use Disclosures

This system contains Protected Health Information (PHI) as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 Code of Federal Regulation Parts 160 and 164, 65 Fed. Reg. 82462 (12-28-00), Subparts A and E. Disclosures of PHI authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.”

In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the population is so small that one could use this information to deduce the identity of the individual).

IV. Safeguards

CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access.

This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook.

V. Effects of the New System on Individual Rights

CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system.

CMS will take precautionary measures (see item IV. above) to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data is maintained in the system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act.

CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of maintaining this system.

Dated: September 19, 2006.

John R. Dyer,

Chief Operating Officer, Centers for Medicare & Medicaid Services.

SYSTEM NUMBER 09-70-0582

System Name:

• “Low Vision Rehabilitation Demonstration (LVRD)” HHS/CMS/ORDI

Security Classification:

Level 3 Privacy Act Sensitive

System Location:

This system is maintained at the Centers for Medicare & Medicaid Services (CMS) Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850, and CMS contractors and agents at various locations.

Categories of Individuals Covered by the System:

The data will be collected and maintained on individual beneficiaries receiving the services and who participate in Medicare Part B fee-for-service coverage, qualified physicians, such as ophthalmologists or optometrists, qualified occupational therapists, and certified low vision therapists, orientation and mobility specialists, and vision rehabilitation therapists (aka rehabilitation teachers) who are certified by the Academy for Certification of Vision Rehabilitation Professionals.

Categories of Records in the System:

The data collected will consist of, but not limited to, clinical quality measures collected from physicians participating in the demonstration. The collected information will contain provider name, unique provider identification number, unique demonstration practice identification number, beneficiary health insurance claim number (HICN), beneficiary demographic and diagnostic information relevant to the project.

Authority For Maintenance Of The System:

The authority for maintenance of this system is given under the provisions of Section 641 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173), enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act.

PURPOSE(S) OF THE SYSTEM:

The primary purpose of the system is to collect and maintain identifiable information on Medicare beneficiaries who participate in Medicare Part B fee-for-service coverage, qualified physicians, such as ophthalmologists or optometrists, qualified occupational therapists, and vision rehabilitation therapists who are certified by the Academy for Certification of Vision Rehabilitation Professionals. Information retrieved from this system will also be disclosed to: (1) Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, consultant, or grantee; (2) assist another Federal or state agency with information to enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; (3) assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects; (4) support litigation involving the agency; and (5) combat fraud, waste, and abuse in certain health benefits programs.

ROUTINE USES OF RECORDS MAINTAINED IN THE SYSTEM, INCLUDING CATEGORIES OR USERS AND THE PURPOSES OF SUCH USES:

A. Entities Who May Receive Disclosures Under Routine Use

The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system:

1. To support agency contractors, consultants, or grantees who have been contracted by the agency to assist in the performance of a service related to this system and who need to have access to the records in order to perform the activity.

2. To assist another Federal or state agency to:

a. Contribute to the accuracy of CMS's proper payment of Medicare benefits,

b. Enable such agency to administer a Federal health benefits program, or as necessary to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds, and/or

3. To assist an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects.

4. To support the Department of Justice (DOJ), court or adjudicatory body when:

a. The agency or any component thereof, or

b. Any employee of the agency in his or her official capacity, or

c. Aany employee of the agency in his or her individual capacity where the DOJ has agreed to represent the employee, or

d. The United States Government is a party to litigation or has an interest in such litigation, and by careful review, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records.

5. To assist a CMS contractor (including, but not necessarily limited to fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such program.

6. To assist another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any state or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs.

B. Additional Provisions Affecting Routine Use Disclosures

This system contains Protected Health Information (PHI) as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 Code of Federal Regulation Parts 160 and 164, 65 Fed. Reg. 82462 (12-28-00), Subparts A and E. Disclosures of PHI authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.”

In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the population is so small that one could use this information to deduce the identity of the individual).

POLICIES AND PRACTICES FOR STORING, RETRIEVING, ACCESSING, RETAINING, AND DISPOSING OF RECORDS IN THE SYSTEM:

STORAGE:

All records are stored on magnetic media.

RETRIEVABILITY:

Information collected will be retrieved by the name or other identifying information of the participating provider, and may also be retrievable by HICN at the individual beneficiary record level.

SAFEGUARDS:

CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access.

This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations include but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. Office of Management and Budget Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook.

RETENTION AND DISPOSAL:

CMS will retain identifiable information maintained in the LVRD system of records for a period of 6 years. Data residing with the designated claims payment contractor shall be returned to CMS at the end of the project, with all data then being the responsibility of CMS for adequate storage and security. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from the DOJ.

SYSTEM MANAGER AND ADDRESS:

Director, Research and Evaluation Group, Office of Research Development and Information, CMS, 7500 Security Boulevard, Mail stop C3-18-07, Baltimore, Maryland, 21244-1850.

NOTIFICATION PROCEDURE:

For purpose of access, the subject individual should write to the system manager who will require the system name, and for verification purposes, the subject individual's name, provider identification number, and the patient's medical record number.

RECORD ACCESS PROCEDURE:

For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2)).

CONTESTING RECORD PROCEDURES:

The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7).

RECORD SOURCE CATEGORIES:

Information maintained in this system will be collected from physicians volunteering to participate in the LVRD Demonstration. Additional data will be collected from Medicare claims payment records.

SYSTEMS EXEMPTED FROM CERTAIN PROVISIONS OF THE ACT:

None.